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Health Canada Increases Filing Fees for Drug Master Files

April 28, 2015

Health Canada has increased Drug Master File (DMF) filing fees, effective as of April 1, 2015. The revised fee structure increases the cost of filing a new DMF to $424 (Canadian), the cost of filing a biannual update to $191 (Canadian), and the cost of filing a Letters of Access to $191 (Canadian).

The DMF program serves as a reference to Health Canada's drug evaluators by providing confidential supplier details that the finished drug product manufacturers do not have. Health Canada began charging user fees for DMF submissions in the 1990s in order to help fund its regulatory programs for drugs.

DMFs are voluntarily submitted to Health Canada by industry members, and contain confidential information with regard to the manufacture of pharmaceutical ingredients, drug substances, packaging materials, colorants, flavor and other additives, and drug products, in order to facilitate the review of pharmaceutical products. Biannual updates are reports that DMF holders are required to submit to Health Canada every two years in order to ensure their DMF retains an "active" status. A Letter of Access authorizes the DMF Holder's customer to make reference to the DMF in their submissions to Health Canada.

The revised DMF Application Fee Form with the updated fees listed can be accessed from Health Canada's website.